Jan 22 2009

Through the CAM Looking Glass

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A newly published systematic review of a controversial anti-migraine drug, migrostat, shows that it works no better than placebo. The review for the Cochrane Collaboration looked at 33 trials, involving a total of 6,736 patients. Those patients treated with migrostat had a reduction of frequency and severity of migraines of about 30%, but this was no better than the placebo group which experienced a similar reduction (there was a “slight” advantage for tension headaches, likely noise in the randomness) – a response rate typical of placebo treatment for subjective symptoms.

The lead author of the review,  Dr. Jacob Bayous, who works for the Pharmaceutical Industry Research Center, is quoted as saying:

“Much of the clinical benefit of migrostat might be due to non-specific effects and powerful placebo effects, meaning selection of specific chemical constituents may be less important than industry proponents have traditionally argued.”

Despite the fact that this review clearly shows that migrostat is no better than placebo – the standard scientific interpretation of which is that it does not work – industry proponents (who are eager to get FDA approval for migrostat) claim that the drug works – “as placebo.” They argue that migraine sufferers still find relief from taking migrostat, and that relief is valuable, even if it is only an effect of the “power of the mind.”

Bayous advocates for further research, saying:

“Doctors need to know how long improvements associated with migrostat will last and whether higher doses of migrostat will achieve better results than lower doses.”

This negative review of migrostat is not the first of its scientific problems. The drug has stalled for years, failing to gain scientific support because it’s “active” ingredient appears to be pharmacologically inert. Evidence suggests it is broken down in the stomach and not absorbed as an intact molecule. In fact, it’s breakdown products are mostly glucose – sugar. It is therefore not surprising that the “drug” is no more effective than placebo. The manufacturer, however, is not willing to give up on what they hope will be a profitable drug.

Dr. Jeremy Kewless from the British Medical Pharmaceutical Society is trying very hard to put a positive spin on these negative results, saying:

“We certainly don’t call migrostat a “placebo”, as we believe there is growing evidence for a mechanism behind the drug.

“However, we still don’t fully understand what is happening pharmacologically, although these reviews suggest that for certain conditions, it is effective.”

Surprisingly, the press is eating up this blatant manipulation. One headline reads:

“Traditional, Non Traditional “Drugs” Both Effective Against Headaches”

So now placebo is a “non traditional drug.”

Are you outraged yet? Imagine the audacity of the pharmaceutical industry – trying to promote a drug that is literally no more than a sugar pill as an effective treatment, in the face of a negative systematic review that shows that it is no more effective than placebo. They actually think they can turn medical science on its head by simply stating that the placebo must also be effective, and calling it a “non traditional drug.” Even more outrageous is the degree to which the mainstream media is simply swallowing this self-serving fiction.

By now you may have seen through my satirical deception. Migrostat is a fiction, but this story isn’t. Simply replace “migrostat” with “acupuncture” and the story is real.  Acupuncture works no better than sham acupuncture. It doesn’t matter where you stick the needles – contradicting the entire basis for acupuncture. Jacob Bayous is really Klause Linde, who works at the Center for Complementary Medicine Research at the Technical University of Munich, Germany. Kewless is Dr Mike Cummings, medical director of the British Medical Acupuncture Society.

Of course, when acupuncture is compared to “placebo acupuncture” using opaque sheaths and dull needles that do not penetrate the skin, there is still no difference. Therefore it not only doesn’t matter where you stick the needles, it doesn’t matter if you stick the needles.

The same is true for other pain conditions. A recent review of the literature concluded, for example:

Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively.

OA is osteoarthritis and LBP is lower back pain – again, not better than sham (i.e. it doesn’t work) but the emphasis is placed on the unblinded (and therefore less reliable) results. If the proponents of acupuncture were honestly science-based, it would have been discarded years ago. But instead proponents have chosen not to listen honestly to the scientific research. Rather they seek to go through the looking glass where black is white and up is down. If their treatment works no better than placebo – then placebos must also be effective. Further they are shifting to uncontrolled and unblinded studies, because those are the ones that generate positive results. Imagine the pharmaceutical industry lobbying the FDA for unblinded trials because double-blind  placebo controlled trials are difficult and often negative.

CAM is all about creatively and deceptively using language to create a double-standard – to defraud the public with ineffective and unscientific treatments.

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